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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ankle Fusion Cage
510(k) Number K242356
Device Name TIDAL Fusion Cage System
Applicant
restor3d, Inc.
4001 NC-54 Hwy, Suite 3160
Durham,  NC  27709
Applicant Contact Brianna Prindle
Correspondent
restor3d, Inc.
4001 NC-54 Hwy, Suite 3160
Durham,  NC  27709
Correspondent Contact Brianna Prindle
Regulation Number888.3020
Classification Product Code
SAI  
Subsequent Product Code
HSB  
Date Received08/08/2024
Decision Date 03/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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